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Tigsun GBS Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref N/AModel 50 testsModel 1 testModel 40 testsModel 100 testsModel 20 testsModel 10 tests
Identity
- Device Name
- Tigsun GBS Antigen Rapid Test EUDAMED
- Model / Reference
- 50 tests EUDAMEDN/A EUDAMED1 test EUDAMED40 tests EUDAMED100 tests EUDAMED20 tests EUDAMED10 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973642381728 EUDAMED06973642381667 EUDAMED06973642381711 EUDAMED06973642381742 EUDAMED06973642381698 EUDAMED06973642381681 EUDAMED
- Basic UDI-DI
- B-06973642381728 EUDAMEDB-06973642381667 EUDAMEDB-06973642381711 EUDAMEDB-06973642381742 EUDAMEDB-06973642381698 EUDAMEDB-06973642381681 EUDAMED
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Tigsun GBS Antigen Rapid Test by Beijing Tigsun Diagnostics Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06973642381728 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Tigsun Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000034480
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (6)
- EUDAMED 77bc83a7-b526-4557-956c-4ad096eaae9c 61 fields · synced Aug 1, 2026
- EUDAMED c493ae88-8179-4630-8f70-79b757ce705a 61 fields · synced May 16, 2026
- EUDAMED 937427d4-4dd6-47fd-b81d-ff4f60fa5f27 61 fields · synced May 17, 2026
- EUDAMED eb4d5f21-2a30-4d86-9cab-8536511cfcb5 61 fields · synced May 18, 2026
- EUDAMED 21177058-9460-4406-bb41-c4c708f55b9c 61 fields · synced May 18, 2026
- EUDAMED 10b73d41-8b33-4717-bc97-5c802b8c2d39 61 fields · synced May 19, 2026